510(k) K990916

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY by Stellar Bio Systems, Inc. — Product Code KTL

K990916 is an FDA 510(k) premarket notification submitted by Stellar Bio Systems, Inc. for the device "INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY". The FDA issued a decision of Substantially Equivalent on April 21, 1999. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Stellar Bio Systems, Inc. has at least 6 other 510(k) clearances on record.